R0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based)

As one of our former FDA colleagues highlights: “You get to work at the forefront of innovation. Working side by side with clients to accelerate therapies that can change patients’ lives.”

If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as a Senior / Vice President, Technical on Parexel’s Regulatory Strategy team (RS)! As a Sr/VP, Tech you’ll work on a variety of assignments, diverse product types for clients with wide-ranging geographical considerations while enjoying fantastic career opportunities and work/life balance all while working from home.

As a critical member of Parexel's Regulatory Strategy team, you’ll be creating opportunity for clients throughout the product lifecycle. Sharing your scientific, technical, regulatory, and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators’ requirements.

You’ll be meeting new situations and learning all the time. In fact, one of the key characteristics you’ll see in our Sr/VP Techs is innate curiosity along with a passion for the science, the industry, and public health.

You’ll be working at a senior / strategic level, and leading teams of respected SMEs in supplying the answers. And, if you’re not already, you’ll soon certainly become a visible figure in the industry.

If you’re committed to public health and want to make a difference, this is the ideal role.

We’re currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel’s highly recognized Regulatory Strategy team!

A Senior/Vice President Technical must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Senior/Vice President Technical must have a thorough understanding of the organization’s consulting models and methodologies, as well as extensive knowledge of what services RS provides. A Senior/Vice President Technical provides a full range of consulting services and works within their personal area of expertise. A Senior/Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities within RS. A Senior/Vice President Technical participates in the development of new service offerings, consulting models and methodologies.

Project Execution

• Works within a team environment or individually based on the project needs

• Works within broad project guidelines and leads issue and conflict resolutions

• Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives

• Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action

• Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions

• Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met

• Manages project engagements (small or large)

• Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support

• Provides guidance to project team members and acts as a mentor to junior staff

Thought Leadership

• Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field

• Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums

• Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met

• Regularly quoted by general and industry news outlets

• When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations

• Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise

• Reinforces the knowledge-centered activities within RS based on their own knowledge and expertise

• Facilitates improvements to the Parexel business processes

• Facilitates new service and consulting model development

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Consulting Activities and Relationship Management

• Adapts the appropriate organization’s consulting models and methodologies when unique situations present themselves as well as designs//improves the methodologies when needed

• Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies

• Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction

• Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined

• Acts as a loaned executive for a client when required

• Facilitates resolutions to possible problems or conflicts within the project team and/or the client

• Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities

• Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry drivers

• Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite

• Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referrals

• Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management

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Requirements

• Education - MD or PhD required

• Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications. Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related Medical role i.e. Clinical Pharmacology Review is strongly preferred, but SMEs with Industry experience will also be considered. Prior depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical

• Extensive Neuroscience, Rare Disease, Immunology, Endocrinology/Metabolism experience is highly preferred.

• The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance

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